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Malakit
Malakit is a Small molecule drug developed by Centre Hospitalier de Cayenne. It is currently in Phase 1 development. Also known as: module B.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Malakit |
|---|---|
| Also known as | module B |
| Sponsor | Centre Hospitalier de Cayenne |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Radical CUREfor MAlaria Among Highly Mobile and Hard-to-reach Populations in the Guyanese Shield (NA)
- Evaluation of a New Malaria Control Strategy Amongst Gold Miners Working Illegally in French Guiana (Malakit) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Malakit CI brief — competitive landscape report
- Malakit updates RSS · CI watch RSS
- Centre Hospitalier de Cayenne portfolio CI
Frequently asked questions about Malakit
What is Malakit?
Who makes Malakit?
Is Malakit also known as anything else?
What development phase is Malakit in?
Related
- Manufacturer: Centre Hospitalier de Cayenne — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: module B
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing